JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES Fortieth Session Berlin, Germany, 26-30

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1 E Agenda item 5 CX/NFSDU 18/40/6-Add.1 JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES Fortieth Session Berlin, Germany, November 2018 Proposed Draft Guideline for Ready-to-Use Therapeutic Foods Replies to CL 2018/64-NFSDU Comments of Argentina, Brazil, Colombia, Ecuador, India, Jamaica, Japan, Malawi, Norway, Sri Lanka, EU Speciality Food Ingredients, HKI, ICAAS, IBFAN, IACFO, IDF, ISDI, MSF, Background 1. This document compiles comments received through the Codex Online Commenting System (OCS) in response to CL 2018/64-NFSDU issued October Under the OCS, comments are compiled in the following order: general comments are listed first, followed by comments on specific sections. Explanatory notes on the appendix 2. The comments submitted through the OCS are hereby attached as Annex I and are presented in table format.

2 CX/NFSDU 18/40/6-Add.1 2 GENERAL COMMENT Colombia supports the proposed text and suggests mentioning the most efficient chemical form for each of the vitamins and minerals that are part of the RUTF. We support the proposed guideline. It's detailed with the right nutrient requirement to treat SAM. Any decisions regarding the suitability and appropriate composition of RUTF must be based on relevant and convincing evidence of efficacy, that is free from commercial influence. IBFAN is of the opinion that current scientific evidence does not support the wide spread use of RUTF products compared to the use of culturally appropriate energy dense family foods for the community management of SAM and MAM and the support of sustained breastfeeding. National Authorities should ensure that any decisions to provide food products are based on sound independent evidence. Such evidence should meet WHO s definition of scientific substantiation: 'Relevant convincing / generally accepted scientific evidence or the comparable level of evidence under the GRADE classification. The evidence should cover the effectiveness of RUTF as a treatment food, resource implications, sustainability, social and economic risks, and how outcomes were measured and risk of bias. (See IBFAN s review of literature in the IBFAN Brief on the Use of RUTF). Access to nutritious and appropriate foods is just one aspect of a full package of treatments and care that are required for sustained rehabilitation of malnourished children and the prevention of recurrence. The protection and support of breastfeeding and culturally appropriate complementary feeding must be a fundamental and an essential component of a rehabilitation package. Other critical components must include: nutrition education; the treatment of infections; support for maternal care; the strengthening of health systems; the prevention of early child bearing; literacy and the improvement of water supply, sanitation and hygiene. The widespread use of RUTF products has and continues to trigger diversion of public funds away from support for sustainable solutions such as breastfeeding and locally sourced, culturally appropriate, bio-diverse family foods. To safeguard against needless and inappropriate use of these products IBFAN is of the opinion that these products should not be on the open market. The marketing and trade of RUTF products introduces a commercial element that increases the risk of unnecessary and inappropriate use. Products that are intended for infant and young child feeding and are legally available on the open market require stringent marketing restrictions in order to protect breastfeeding, complementary feeding and child health from commercial influence. For this reason the marketing of breastmilk substitutes and related products are all covered by the International Code of Marketing and subsequent relevant WHA Resolutions. Similarly, these safeguards are needed for products intended for this vulnerable population. RUTFs intended for therapeutic use only and although the International Code and WHA resolutions provide some important safeguards, extra safeguards are needed to prevent misuse. Since Codex Guidelines are voluntary instruments, for the safety aspects to be effective, they must be implemented into national law. Codex texts dealing with food safety are already integrated into the regulatory mechanisms of many countries. National authorities can use these to improve the safety of products (eg. Codex Code of Practice for Low-Moisture Foods (CAC/RCP ). Importantly, this Codex Guideline is being developed through a process, which is not adequately safeguarded from conflicts of interest. Undue influence from manufacturers and distributors, their associations and the organizations funded by them is likely to subvert the public health purpose. It will lead to increased global trade of a single commodity and its widespread use at the expense of sustainable solutions. Manufacturers and distributors might also put pressure on governments to accept imports of products that may not be needed or wanted. To facilitate sound decision making on this important topic, the support to the process being pursued in the CCNFSDU, needs to include more robust evidence of the validity of using RUTF in community management of SAM. Lack of such evidence and concern about the marketing and misuse of these products continues. The scope of RUTF has been limited in the recent management of SAM children of Rohingya refugees in Bangladesh. Mothers and caretakers successfully managed SAM children with their own home-prepared foods, which they use for home foods. These children improved within two months, completely gaining to 0 Z score of WH after feeding. The ingredients were rice powder, soya oil, sugar and egg. The cost is nominal cents per day. Ingredients were supplied and mothers were shown how to cook in their camp house. Every family MEMBER / OBSERVER Colombia Ghana International Association of Consumer Food Organizations International Baby Food Action Network

3 CX/NFSDU 18/40/6-Add.1 3 had cooking facilities. The intervention was followed with a two-month observation period without supply of ingredients but alongside continued advice on family feeds. IUFoST supports the concept of these guidelines for special food products used to meet dietary requirements of children with severe malnutrition. With regard to the name, consideration should be given to the need for the word "therapeutic" since this could cause legal problems in some countries. Therapeutic implies treatment of diseases, which could make such products drugs under laws in many countries. Microbiological and Chemical Contaminant Criteria IUFOST will provide a report to share at the physical working group meeting reviewing contaminant risks. notes that it is convention to refer to primary codex texts for microbial and contaminant specification criteria. While respecting this convention, allows for efficient updating of codex texts, we find that partners and suppliers appreciate the ease of having specific criteria listed in the one reference document. SPECIFIC COMMENTS PREAMBLE (Recommendation 1) Argentina agrees with this preamble Children affected by severe acute malnutrition (SAM) need safe, palatable foods with a high energy content and adequate amounts of vitamins, minerals and other nutrients. Children with SAM need efficacious and timely treatment and RUTF is may be part of the care. RUTF are primarily intended for children with uncomplicated SAM from 6-59 months. Although RUTF may be given to other age groups with various forms of malnutrition at the implementation level, the primary focus for these guidelines is children with SAM from 6-59 months. Since RUTF are prescribed according to weight, National Authorities may decide to include the provision of RUTF in their national protocols for use by other age groups. 1) A Joint Statement by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children s Fund Community-Based Management of Severe Acute Malnutrition; A Joint Statement by the World Health Organization and the United Nations Children's Fund Child growth standards and the identification of severe acute malnutrition in infants and children, Geneva: World Health Organization; World Health Organisation Guideline: Updates on the management of severe acute malnutrition in infants and children, Geneva: World Health Organization; World Health Organisation Global Strategy for Infant and Young Child Feeding, Geneva: World Health Organization; World Health Organisation International code of marketing of breast-milk substitutes, Geneva: World Health Organization and subsequent relevant WHA Resolutions on infant and young child feeding; Code of Ethics for International Trade in Food including Concessional and Food Aid Transactions (CXC ); Food and Agriculture Organisation and World Health Organisation FAO/WHO Microbial safety of lipid-based ready-to-use foods for management of moderate acute malnutrition and severe acute malnutrition, Rome: Food and Agriculture Organisation. Argentina Brazil Brazil would like to suggest some amendments in the proposed text. We are of the opinion that the text should not emphasize the use of RUTF because the focus should be on foods locally available. Brazil also suggests including in the footnote the full reference of WHA Resolutions and Ending inappropriate promotion of foods for infants and young children. WHA urged Member States to end inappropriate promotion of food for infants and young children, and to ensure that nutrition and health claims shall not be permitted for foods for infants and young children, except where specifically provided for in relevant Codex Alimentarius standards or national legislation. WHA 69.9 recognizes the role of the Codex Alimentarius Commission and requests that reviews of Codex Standards and Guidelines should give full consideration to WHO guidelines and recommendations, including the International Code of Marketing of Breast-milk Substitutes and relevant WHA resolutions: 1)Joint Statement on Community-Based Management of

4 CX/NFSDU 18/40/6-Add.1 4 Children affected by severe acute malnutrition (SAM) need safe, palatable foods with a high energy content and adequate amounts of vitamins, minerals and other nutrients. Children with SAM need efficacious and timely treatment and RUTF is part of the care. RUTF are primarily intended for children with uncomplicated SAM from 6-59 months. Although RUTF may be given to other age groups with various forms of malnutrition at the implementation level, the primary focus for these guidelines is children with SAM from 6-59 months. Since RUTF are prescribed according to weight, National Authorities may decide to include the provision of RUTF in their national protocols for use by other age groups. groups and other forms of malnutrition such as moderate acute malnutrition. Children affected by severe acute malnutrition (SAM) need safe, palatable foods with a high energy content and adequate amounts of vitamins, minerals and other nutrients. Children with SAM need efficacious and timely treatment and RUTF is part of the care. RUTF are primarily intended for children with uncomplicated SAM from 6-59 months. Although RUTF may be given to other age groups with various forms of malnutrition at the implementation level, the primary focus for these guidelines is children with SAM from 6-59 months. Since RUTF are prescribed according to weight, National Authorities may decide to include the provision of RUTF in their national protocols for use by other age groups. groups and other forms of malnutrition such as moderate acute malnutrition. Having guidelines for ready-to-consume therapeutic foods will allow countries to manufacture these products so that they are suitable for the treatment of acute malnutrition in children aged 6 to 59 months. However, it is essential to have parameters so that the products that are manufactured meet the intended purpose. It is also important to emphasise that this food in no way replaces breast milk and, therefore, the messages that are included on the labels of these products should indicate the importance of continuing to provide breast milk to ensure a better response. In addition, it should be noted that these foods can be manufactured from local foods with a high nutritional value as Severe Acute Malnutrition by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children s Fund, 2007; WHO. Child growth standards and the identification of severe acute malnutrition in infants and children, 2006; A Joint Statement by the World Health Organization and the United Nations Children's Fund; Geneva: World Health Organization; 2009; WHO. Guideline: Updates on the management of severe acute malnutrition in infants and children. Geneva: World Health Organization; 2013; WHO. Global Strategy for Infant and Young Child Feeding. Geneva: World Health Organization; 2003; WHO. International code of marketing of breast-milk substitutes. Geneva: World Health Organization; 1981, WHA Resolutions and Ending inappropriate promotion of foods for infants and young children, and subsequent relevant WHA Resolutions on infant and young child feeding; Code of Ethics for International Trade in Food including Concessional and Food Aid Transactions (CAC/RCP ; FAO/WHO microbial risk assessment report (FAO/WHO Microbial safety of lipid-based ready-to-use foods for management of moderate acute malnutrition and severe acute malnutrition; Colombia Bearing in mind that in Colombia as in other countries FTLC is used for the treatment of moderate acute malnutrition (<-2 SD) and severe acute malnutrition (<-3 SD), we recommend the following adjustment in the preamble. Bearing in mind that in Colombia as in other countries FTLC is used for the treatment of moderate acute malnutrition (<-2 SD) and severe acute malnutrition (<-3 SD), we recommend the following adjustment in the preamble. Ecuador

5 CX/NFSDU 18/40/6-Add.1 5 well as from culturally accepted local foods. Purpose of the guidelines We agree with the planned guidelines. This type of product is aimed at young children; therefore, the specifications for these products must be strict to ensure the safety of the children. Older infants and Children affected by severe acute malnutrition (SAM) need safe, palatable foods with a high energy content and adequate amounts of vitamins, minerals and other nutrients. Children with SAM need efficacious and need timely treatment and RUTF is part of the care. RUTF are primarily is intended for children with uncomplicated SAM from 6-59 months. Although RUTF may be given Other options include augmented home prepared foods. It is important to other age groups with various forms of malnutrition at the implementation levelsustain breastfeeding and homemade, the primary focus for these guidelines is children with SAM from 6-59 monthsculturally acceptable complementary foods. Since RUTF It is absolutely necessary that RUTFs are prescribed according to weight, National Authorities may decide to include the provision of RUTF in their national protocols used only under Medical Supervision for use by other children in the age groups. group of 6 59 months. These guidelines provide guidance for the production and labelling of RUTF. The guidelines are intended to facilitate the harmonization and standardization of requirements production of for RUTF at the international level and may provide assistance to governments wishing to establish national regulations as per their policy regulations. The guidelines are also intended for use as an instrument designed to avoid or remove difficulties which may be created by diverging legal, administrative and technical approaches to RUTF and by varying definitions and nutrient compositions of RUTFRUTF products. These guidelines should be used in accordance with technical recommendations of the relevant evidence and evidence related Codex texts/documents by WHO, and WFP 11 and relevant National regulations of the implementing Nation. Governments and other users should ensure adequate provisions are made for competent technical experts for the appropriate use of these guidelines. so that these products are used only to treat SAM under strict medical supervision and to avoid general use of them. 1) A Joint Statement by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children s Fund Community-Based Management of Severe Acute Malnutrition; A Joint Statement by the World Health Organization and the United Nations Children's Fund Child growth standards and the identification of severe acute malnutrition in infants and children, Geneva: World Health Organization; World Health Organisation Guideline: Updates on the management of severe acute malnutrition in infants and children, Geneva: World Health Organization; World Health Organisation Global Strategy for Infant and Young Child Feeding, Geneva: World Health Organization; World Health Organisation International code of marketing of breast-milk substitutes, Geneva: World Health Organization and subsequent relevant WHA Resolutions on infant and young child feedingfeeding and the WHO Guidance on ending inappropriate marketing of foods for infant and young children; Code of Ethics for International Trade in Food including Concessional and Food Aid Transactions (CXC ); Food and Agriculture Organisation and World Health Organisation FAO/WHO Microbial safety of lipid-based ready-to-use foods for management of moderate acute malnutrition and severe acute malnutrition, Rome: Food and Agriculture Organisation. India 1. India does not support the use of RUTF as enough evidence is not available for the use of commercially manufactured RUTF for management of SAM vis-a-vis other interventions like home augmented foods. Further, in a recent trial conducted in India comparing the efficacy of RUTF (centrally produced and locally produced) with augmented energy-dense home-prepared foods (comparison group) for home based management of uncomplicated severe acute malnutrition (SAM); results showed that (i) homemade foods were as effective vis-a-vis as centrally produced RUTF; (ii) 16 weeks after stopping RUTF, recovery rates dropped from 56.9% to 17.3% for locally produced RUTF and from 47.5% to 12.1% for centrally produced RUTF and not for use of these products in India. 2. India strongly supports the need for using local foods to manage the condition in accordance with the national policy. Therefore, the comments of India are limited only to the guideline formulation process for standardization of the product. 3. Further, if the use of RUTF in national/sub-national programme for the management of SAM is approved by the national authorities, these formulations should meet the relevant country specific recommendations for Essential composition as specified by the National Authorities and a footnote to this effect should be inserted under the recommendation for each Nutrient (macronutrients as well as micronutrients). 1. The statement Since RUTF is prescribed according to weight, National Authorities may decide to include the provision of RUTF in their national protocols for use by other age groups may be deleted as enough scientific evidence is not available to recommend their use in age groups beyond the age of 5 years. Moreover, the use of RUTF by other agegroups is not under the scope of these guidelines. 2. Reference for the relevant WHA resolutions needs to be given in the footnote. 3. *Other Nutrients needs to be specified. 4. Additional suggested changes have been highlighted

6 CX/NFSDU 18/40/6-Add.1 6 Children affected by severe acute malnutrition (SAM) need safe, palatable foods with a high energy content and adequate amounts of protein, vitamins, minerals and other nutrients. Children with SAM need efficacious and timely treatment and RUTF is part of the care. RUTF are primarily intended for children with uncomplicated SAM from 6-59 months. Although RUTF may be given to other age groups with various forms of malnutrition at the implementation level, the primary focus for these guidelines is children with SAM from 6-59 months. Since RUTF are prescribed according to weight, National Authorities may decide to include the provision of RUTF in their national protocols for use by other age groups. To provide guidance on technical and nutritional aspects of the production of Ready to Use Therapeutic Foods for children from the age of 6 to 59 months with severe acute malnutritionwith uncomplicated severe acute malnutrition, including Children affected by severe acute malnutrition (SAM) need safe, palatable foods with a high energy content and adequate amounts of vitamins, minerals and other nutrients. Children with SAM need efficacious and timely treatment and RUTF is part of the care. RUTF are primarily intended for children with uncomplicated SAM from 6-59 months. Although RUTF may be given to other age groups with various forms of malnutrition at the implementation level, the primary focus for these guidelines is children with SAM from 6-59 months. Since RUTF are prescribed according to weight-, National Authorities may decide to include the provision of RUTF in their national protocols for use by other age groups. 1) A Joint Statement by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children s Fund Community-Based Management of Severe Acute Malnutrition; A Joint Statement by the World Health Organization and the United Nations Children's Fund Child growth standards and the identification of severe acute malnutrition in infants and children, Geneva: World Health Organization; World Health Organisation Guideline: Updates on the management of severe acute malnutrition in infants and children, Geneva: World Health Organization; World Health Organisation Global Strategy for Infant and Young Child Feeding, Geneva: World Health Organization; -World Health Organisation ; International code of marketing of breast-milk substitutes, Geneva: World Health Organization and subsequent relevant WHA Resolutions on infant and young child feeding; Code of Ethics for International Trade in Food including Concessional and Food Aid Transactions (CXC ); Food and Agriculture Organisation and World Health Organisation FAO/WHO Microbial safety of lipid-based ready-to-use foods for management of moderate acute malnutrition and severe acute malnutrition, Rome: Food and Agriculture Organisation. Children affected by severe acute malnutrition (SAM) need safe, palatable foods with a high energy content and adequate amounts of vitamins, minerals and other nutrients. Children with SAM need efficacious and timely treatment and RUTF is part of the care. RUTF are primarily intended for children with uncomplicated SAM from 6-59 months. Although RUTF may be given to other age groups with various forms of malnutrition at the implementation at appropriate place in the text of the preamble. Sri Lanka HKI From the preamble above ("RUTF are primarily intended for children with uncomplicated SAM from 6-59 months") we understood that RUTF was meant for dietary management of severe acute malnutrition with no medical complications as per the 2007 Joint statement. Yet the purpose of the guidelines does not mention the term uncomplicated SAM. To be consistent HKI suggests consideration of following phrasing: To provide guidance on technical and nutritional aspects of the production of Ready to Use Therapeutic Foods for children from the age of 6 to 59 months with uncomplicated severe acute malnutrition, including ISDI would like to highlight that RUTFs are not prescribed according to weight and therefore this statement should be removed from the text of the preamble. As regards to Footnote 1, ISDI notes that the Joint Statement on Community-Based Management of Severe Acute Malnutrition by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children s Fund, 2007 was updated in In addition, as RUTF is not breastmilk substitutes, ISDI questions the reference to guidelines included as part of Footnote 1. International Association of Consumer Food Organizations

7 CX/NFSDU 18/40/6-Add.1 7 level, the primary focus for these guidelines is children with SAM from 6-59 months. Since RUTF are prescribed according to weight, National Authorities may decide to include the provision of RUTF in their national protocols for use by other age groups. RUTFs may be used as a treatment food for older infants and young children with severe acute malnutrition (SAM), when other nutrient rich foods cannot be used. However, it is critical that its use does not undermine support for continued breastfeeding or relactation, since this is the most important requirement for the rehabilitation of children suffering from malnutrition. RUTFs can be used as a treatment food while breastfeeding is re-established and sustained and family foods are gradually introduced. The portion size of RUTFs should be adapted to ensure optimal breastmilk intake. RUTFs can also be used for the feeding of malnourished older infants and young children in emergency situations. These guidelines provide guidance for the production and labelling of RUTFRUTF products. The guidelines are intended to facilitate ensure that the harmonization of requirements ingredients, nutritional composition, safety and labeling is appropriate for RUTF at the international level intended recipients and may to provide assistance to governments wishing to establish national regulations. The guidelines are also intended for use as an instrument designed to avoid or remove difficulties which may be created by diverging legal, administrative and technical approaches to RUTF and by varying definitions and nutrient compositions of RUTF. These guidelines should be used in accordance with technical recommendations of that are based on the relevant evidence and related Codex texts/documents by WHOfree from commercial influence, taking into account relevant Codex texts related to food safety and WFPhygiene 1. Governments and other users should ensure adequate provisions are made for with competent technical experts for to ensure that the use of these products is appropriate in the local context and does not undermine national nutrition recommendations and the use of biodiverse, culturally appropriate foods. If RUTF are considered appropriate, they should be used solely for treatment purposes and not for general use or the prevention of SAM. Appropriate steps must be taken to ensure that there is no "spillover" to the wider population and the black market. On no account should RUTF products be placed on the open market for general sale or promoted in any way. The production and availability of these guidelinesproducts must comply with the relevant provisions of the WHO International Code of Marketing of Breastmilk Substitutes, the subsequent relevant WHA resolutions, including WHA 69.9, its accompanying WHO Guidance on Ending the Inappropriate Promotion of Foods for Infants and Young Children and the Codex Guidelines on Nutrition and Health Claims. Paragraph 1.4 of which states that no nutrition and health claims should be made for foods for infants and young children. Convenience and other promotional claims should also not be made for these products, on labels or information materials. Children affected by severe acute malnutrition (SAM) need [adequate treatment and care] OR [safe, palatable foods with a high energy content and adequate amounts of vitamins, minerals and other nutrients. Children with SAM need timely treatment and RUTF is a critical part of the care]. RUTF are primarily intended for children with uncomplicated SAM from 6-59 months. Although RUTF may be given to other age groups with various forms of malnutrition at the implementation level, the primary focus for these guidelines is children with SAM from 6-59 months. Since RUTF are prescribed according to weight, National Authorities may decide to include the provision of RUTF in their national protocols for use by other age groups. RUTFs may be used as a treatment food for older infants and young children with SAM, when other nutrient rich foods cannot be used. However, it is critical that its use does not undermine support for continued breastfeeding or to re-establish lactation, since this is the most important requirement for the rehabilitation of children suffering from malnutrition. RUTFs can be used as a treatment food while breastfeeding is sustained and family foods are gradually introduced. The portion size of RUFTs should be adapted to ensure optimal breastmilk intake. RUTFs can also be used for the feeding of malnourished older infants and young children in emergency situations. International Association of Consumer Food Organizations

8 CX/NFSDU 18/40/6-Add.1 8 These guidelines provide requirements for the production and labelling of RUTF products. The guidelines are intended to ensure that the that the facilitate the harmonization of ingredients, nutritional composition, safety, use and labelling is appropriate for the intended recipients, requirements for RUTF at the international level and and to provide assistance to governments wishing to establish national regulations. The guidelines are also intended for use as an instrument designed to avoid or remove difficulties which may be created by diverging legal, administrative and technical approaches to RUTF and by varying definitions and nutrient compositions of RUTF. These guidelines should be used in accordance with technical recommendations that are based and updated on relevant and convincing evidence free from commercial influence, taking into account relevant Codex texts related to food safety and hygiene1. Governments and other users should ensure adequate provisions are made for with competent technical experts to ensure that the use of these products is appropriate in the local context, does not undermine national nutrition recommendations and the use of bio-diverse, culturally appropriate foods. If RUTFs are considered appropriate, they should be used solely for treatment purposes and not for general use or the prevention of SAM. Steps must be taken to ensure that there is no spillover into the wider population and the black market. On no account should RUTF products be placed on the open market. The production and availability of these products must comply with the relevant provisions of the WHO International Code of Marketing of Breastmilk Substitutes, the subsequent relevant WHA resolutions including the WHA 69.9, its accompanying WHO Guidance on Ending the Inappropriate Marketing of Foods for Infants and Young Children and the Codex Guidelines on Nutrition and Health Claims, Paragraph 1,4 of which states that no nutrition and health claims should be made for foods for infants and young children. Nor should convenience claims be made for these products on labels or information materials. 1)Joint Statement on Community-Based Management of Severe Acute Malnutrition by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children s Fund, 2007; WHO. Child growth standards and the identification of severe acute malnutrition in infants and children, 2006; A Joint Statement by the World Health Organization and the United Nations Children's Fund; Geneva: World Health Organization; 2009; WHO. Guideline: Updates on the management of severe acute malnutrition in infants and children. Geneva: World Health Organization; 2013; WHO. Global Strategy for Infant and Young Child Feeding. Geneva: World Health Organization; 2003; WHO. International code of marketing of breast-milk substitutes. Geneva: World Health Organization; 1981 and subsequent relevant WHA Resolutions on infant and young child feeding; Code of Ethics for International Trade in Food including Concessional and Food Aid Transactions (CAC/RCP ; FAO/WHO microbial risk assessment report (FAO/WHO Microbial safety of lipid-based ready-to-use foods for management of moderate acute malnutrition and severe acute malnutrition; vii. Recommendations for safe use as a therapeutic food only viii. Recommendations to restrict marketing to avoid spill-over and needless use. PURPOSE OF THE GUIDELINES To provide guidance on technical and nutritional aspects of the production of Ready to Use Therapeutic Foods for children from the age of 6 to 59 months with severe acute malnutrition, including i. Nutritional Composition ii. Raw Materials and Ingredients iii. Good Manufacturing Practices iv. Microbiological and Chemical Contaminant Criteria v. Methods of Analysis and Sampling vi. Provisions for Packaging and Labelling vii. Recommendations for safe use as a therapeutic food only IBFAN

9 CX/NFSDU 18/40/6-Add.1 9 viii. Recommendations to restrict marketing to avoid spill-over and needless use. SCOPE The provisions of these guidelines apply to Ready to Use Therapeutic Foods for children from age 6 to 59 months with severe acute malnutrition. Ready-to-Use Supplementary Foods (RUSF), micronutrient supplements2, processed cereal based foods3, formulated complementary foods for older infants and young children4, canned baby foods5 are not specifically covered by these guidelines. To prevent spill over and inappropriate use, the marketing restrictions recommended in this guideline should apply to all products that target malnourished children. RUTFs are to be used for therapeutic use only and not available on the general market. 2)Guidelines for Vitamin and Mineral Food Supplements (CXG ) 3Standard for Processed Cereal-Based Foods for Infants and Young Children (CXS ) 4Guidelines on Formulated Complementary Foods for Older Infants and Young Children (CXG ) 5Standard for Canned Baby Foods (CXS ) The provisions of these guidelines apply to Ready to Use Therapeutic Foods for children from age 6 to 59 months with severe acute malnutrition. Ready-to-Use Supplementary Foods (RUSF), micronutrient supplements 2, processed cereal based foods 3, formulated complementary foods for older infants and young children 4, canned baby foods 5 are not covered by these guidelines. However, in order to prevent spill-over and inappropriate use, the marketing restrictions recommended in this guideline should apply to all products that target malnourished children. RUTFs are to be used for therapeutic use only and not available on the general market. The provisions of these guidelines apply to Ready to Use Therapeutic Foods for children from age 6 to 59 months with severe acute malnutrition. Ready-to-Use Supplementary Foods (RUSF), micronutrient supplements 2, processed cereal based foods 3, formulated complementary foods for older infants and young children 4, canned baby foods 5 are not covered by these guidelines. : HKI supports the text as proposed. IBFAN International Association of Consumer Food Organizations should this be a colon? (editorial) HKI 4. DESCRIPTION 4.1 Ready-to-Use Therapeutic Foods (RUTF) are foods for special medical purposes and are high-energy and contain adequate protein and other essential nutrients for the dietary management of children from 6 to 59 months with severe acute malnutrition without medical complications with appetite. These foods should be soft or crushable and should be easy for children to eat without any prior preparation. We agree with the provisions of the guidelines, but we suggest adding the management of children from 6 to 59 months with severe acute and moderate acute malnutrition without medical complications. HKI supports the text as proposed. Ecuador HKI 4.1 Ready-to-Use Therapeutic Foods (RUTF) are foods. 6 to 59 months with severe acute malnutrition without medical complications with appetite. These foods should be soft or crushable and should be easy for children to eat without any prior preparation. 4.1 Ready-to-Use Therapeutic Foods (RUTF) are foods. 6 to 59 months with severe acute malnutrition without medical complications with appetite. RUTF are made of ingredients embedded in a lipid-rich matrix e.g. paste or biscuit, resulting in an energy and nutrient-dense food. These foods should be soft or crushable and should be easy for children to eat without any prior preparation. 4.1 Ready-to-Use Therapeutic Foods (RUTF) are foods for special medical purposes and are high-energy and contain adequate protein and other essential nutrients for the dietary management of children from 6 to 59 months with severe acute malnutrition without medical complications with appetite. These foods should be soft or crushable and should be easy for children to eat without any prior preparation. MSF The term "soft or crushable" shall be removed, to allow the formulation of new RUTF such as liquid ready to use, etc... Furthermore, existing lipid based RUTF paste is not soft or crushable... IBFAN

10 CX/NFSDU 18/40/6-Add Severe Acute Malnutrition is defined by weight for height (or length) less than 3 Z-score of the median WHO growth standards, or by mid upper arm circumference (MUAC)<11.5 cm, or by the presence of bilateral oedema. 4.2 Severe Acute Malnutrition is defined by weight for height (or length) less than 3 Z-score of the median WHO Colombia growth standards, or and by mid upper arm circumference (MUAC)<11.5 cm, or and by the presence of bilateral Additionally, it is proposed to include the definition of moderate oedema.. acute malnutrition because in Colombia as in other countries 4.3 Moderate acute malnutrition: weight-height ratio (or stature) less than two z-scores below the median of WHO FTLC is used for the treatment of moderate acute malnutrition growth patterns. (<-2 SD) and severe acute malnutrition (<-3 SD). We agree with the definition of severe acute malnutrition, but we also suggest including the definition of moderate Ecuador acute malnutrition with the following text: Moderate acute malnutrition occurs when the Z score of the W/H indicator is between -2 and -3DE. It may be accompanied by some degree of emaciation or thinness due to recent weight loss. 4.2 Severe Acute Malnutrition is defined by weight for height (or length) less than 3 Z-score of the median WHO Jamaica growth standards, or by mid upper arm circumference (MUAC)<11(MUAC) <11.5 cm, or by the presence of bilateral oedema. 4.2 Severe Acute Malnutrition is defined by weight for height (or length) less than 3 Z-score of the median WHO IBFAN growth standards, or by mid upper arm circumference (MUAC)<11.5 cm, or by the presence of bilateral oedema. 4.2 Severe Acute Malnutrition is defined by weight for height (or length) less than 3 Z-score of the median WHO growth standards, or by mid upper arm circumference (MUAC)<11.5 cm, or by the presence of bilateral oedema. suggest to include a reference to the WHO guideline. WHO. Guideline: Updates on the management of severe acute malnutrition in infants and children. Geneva: World Health Organization; SUITABLE RAW MATERIALS AND INGREDIENTS RUTF are made of ingredients embedded in a lipid-rich matrix e.g. paste or biscuit, resulting in an energy and nutrient-dense food. The following raw materials, many of which can be sourced locally, are suitable ingredients for the production of RUTF under the specified conditions given below. The formulation of RUTF shall comply with Section 3 of the Standard for the Labelling of and Claims for Foods for Special Medical Purposes (CXS ). ISDI would like to raise a comment which is out of the scope of the recommendation put forward by the ewg Chair. The comment concerns para 5 SUITABLE RAW MATERIALS AND INGREDIENTS in the Proposed Draft Guidelines. The introduction of the paragraph refers to section 3 of the Standard for Labelling of and Claims for Foods for Special Medical Purposes (CXS ), however, ISDI believes it should be clearly mentioned in the Guidelines that alternative ingredients to peanut in RUTF should be submitted to efficacy studies. Rationale: alternative ingredients to peanut in RUTF may have significant impact on quality, safety and efficacy of the product. Appropriate studies should therefore be conducted at all necessary levels, not only to avoid contaminants but also to guarantee that such products, which may eventually be given to treat children affected by SAM, are as safe, acceptable and efficacious as the now well-established peanut formula. material used, adequate processing steps may have to be selected in order to guarantee its microbiological quality, nutritional quality and the absence of off-flavours. drying, extrusion etc.) may contribute to reaching the microbiological specifications. However, the challenge to maintain the high microbiological quality on the long run may be more related to compliance with Good Manufacturing Practices (packaging steps, storage etc.).

11 CX/NFSDU 18/40/6-Add.1 11 ot have the same impact on the nutritional quality of these raw materials. For example, roasting will usually help solving the off-tastes and the potential microbiology issues, but will only have a limited impact on the starch gelatinization in cereals, which is a key issue. This should be addressed beforehand, when selecting the plant raw materials and the corresponding processing steps. Any decisions regarding the suitability and appropriate composition of RUTF must be based on relevant and convincing evidence of efficacy, which is free from commercial influence. RUTF are made of ingredients embedded in a lipid-rich matrix e.g. paste or biscuit, resulting in an energy and nutrient-dense food. The following raw materials, many of which can be sourced locally, are suitable ingredients for the production of RUTF under the specified conditions given below. The formulation of RUTF shall comply with Section 3 of the Standard for the Labelling of and Claims for Foods for Special Medical Purposes (CXS ). Ingredients produced from genetically modified organisms shall not be used in the production of RUTFs. Ingredients must be produced and processed to ensure that they are safe and suitable for consumption by this vulnerable population. RUTF are made of ingredients embedded in a lipid-rich matrix e.g. paste or biscuit, resulting in an energy and nutrient-dense food. The following raw materials, many of which can be sourced locally, are suitable ingredients for the production of RUTF under the specified conditions given below. The formulation of RUTF shall comply with recommended that each raw material envisaged for use in RUTF should be evaluated for their content in: o gelatinized starch (considered as easily digestible), for cereals and pulses o anti-nutritional factors such as phytates (which can limit iron and zinc absorption) and anti-trypsic factors. More broadly, it should be noted that changing a significant part of the raw materials in RUTF may influence the digestibility and bioavailability of the nutrients, which may impact the efficacy of the finished product. This is all the more critical as these products are to be given to sick, SAM-affected children, whose digestive system is not functioning properly. Therefore, ISDI strongly recommends that any new RUTF formula incorporating alternative ingredients is thoroughly validated through acceptability, efficacy and (if appropriate) effectiveness studies, conducted by independent third parties. As a consequence, ISDI recommends the addition of the following sentence at the end of the introduction of the para 5. This section includes cereals, pulses and seeds as possible ingredients to prepare RUTF. These ingredients are not used in most current formulations of RUTF. Any RUTF should be shown to be efficacious in clinical trials before being introduced in programmes. IBFAN International Association of Consumer Food Organizations

12 CX/NFSDU 18/40/6-Add.1 12 Section 3 of the Standard for the Labelling of and Claims for Foods for Special Medical Purposes (CXS ). Ingredients used must be grown under conditions that ensure the product is fit for human consumption. RUTF are made of ingredients embedded in a lipid-rich matrix e.g. paste or biscuit, resulting in an energy and nutrient-dense food. The following raw materials, many of which can be sourced locally, are suitable ingredients for the production of RUTF under the specified conditions given below. The formulation of RUTF shall comply with Section 3 of the Standard for the Labelling of and Claims for Foods for Special Medical Purposes (CXS ) Milk and other Dairy Products Milk and other dairy products used in the manufacturing of RUTF must comply with the Standard for Milk Powders and Cream Powder (CXS ) and the Standard for Whey Powders (CXS ), and other Codex milk and milk product standards as well as other guidelines and Codes of Practice recommended by Codex Alimentarius Commission which are relevant to these products. Relevant codes of practice include the Code of Hygienic Practice for Milk and Milk Products (CXC ) and the Code of Hygienic Practices for Low-Moisture Foods (CXC ). Milk and or other dairy products used in the MSF and shall be removed by OR Milk and other dairy products products, including other animal milk sources, used in the manufacturing of RUTF must comply with. and the Code of Hygienic Practices for Low-Moisture Foods (CXC ) ) and the Code of Hygienic Code of Practice for Powdered Infant Formula (CAC/RCP ). Milk and other dairy products, including other animal milk sources, used in the manufacturing of RUTF must comply with the Standard for Milk Powders and Cream Powder (CXS ) and the Standard for Whey Powders (CXS ), and other Codex milk and milk product standards as well as other guidelines and Codes of Practice recommended by Codex Alimentarius Commission which are relevant to these products. Relevant codes of practice include the Code of Hygienic Practice for Milk and Milk Products (CXC ) and the Code of Hygienic Practices for Low-Moisture Foods (CXC ), and the Code of Hygienic Code of Practice for Powdered Infant Formula (CAC/RCP ). International Association of Consumer Food Organizations Legumes and Seeds Legumes and seeds such as soybeans, lentils, chickpeas, cowpeas, beans, peanut, sesame and other types of legumes and seeds must comply with the relevant Codex Alimentarius texts when used in the manufacturing of RUTF. Legumes and pulses must be appropriately processed to reduce, as much as possible, the anti-nutritional factors normally present, such as phytate, lectins (haemagglutenins), trypsin and chymotrypsin inhibitors. We suggest adding locally produced seeds and beans, such as chocho beans, broad beans, sambo seeds and Ecuador squash seeds, among others. Legumes and pulses must be appropriately processed to reduce, as much as possible, the anti-nutritional factors normally present, such as phytate, lectins (haemagglutenins)(haemagglutinins), trypsin and chymotrypsin inhibitors. Legumes and pulses must be appropriately processed to reduce, as much as possible, the anti-nutritional factors normally present, such as phytate, lectins (haemagglutenins), trypsin and chymotrypsin inhibitors.inhibitors and phytoestrogens Lectins can be reduced by moist heat treatment. Trypsin inhibitor activity may be reduced to acceptable levels by heating to high temperatures or by prolonged boiling. Phytate can be reduced enzymatically or by soaking or fermentation. Phytoestrogens can be reduced by fermentation. Field beans or Faba beans (Viciafaba L) should not be used in the formulation of RUTF because of the danger of favism. Heat treatment does not completely inactivate the toxic components (vicine and co-vicine) Legumes and pulses seeds must be appropriately processed to reduce, as much as possible, the anti-nutritional factors normally present, such as phytate, lectins (haemagglutenins), trypsin and chymotrypsin inhibitors. IBFAN similar text is used in the GUIDELINES ON FORMULATED COMPLEMENTARY FOODS FOR OLDER INFANTS AND YOUNG CHILDREN CAC/GL (2017).

13 CX/NFSDU 18/40/6-Add.1 13 Legumes and seeds such as soybeans, lentils, chickpeas, cowpeas, beans, peanut, sesame and other types of legumes and seeds must comply with the relevant Codex Alimentarius texts when used in the manufacturing of RUTF. Legumes and seeds pulses must be appropriately processed to reduce, as much as possible, the anti-nutritional factors normally present, such as phytate, lectins (haemagglutenins), trypsin and chymotrypsin inhibitors Legumes and Seeds Cereals We suggest adding the type of fats and oils that may be used. The use of trans fats should be restricted We suggest adding grains with high nutritional value, such as quinoa Vitamins and Minerals (Recommendation 2) Argentina agrees with this recommendation about vitamins and minerals Regarding the minerals salts and vitamins specified in the WHO Management of severe malnutrition: A manual for physicians and other senior health workers (1999), Brazil notes that these compounds (potassium chloride, tripotassium citrate, magnesium chloride, zinc acetate, copper sulfate, sodium selenite, potassium iodide) are already listed in CAC/GL Moreover, we do not find specific vitamins compounds in the WHO document. Thus, Brazil considers that the reference of CAC/GL is enough Colombia supports the proposed text and suggests mentioning the most efficient chemical form for each of the vitamins and minerals that are part of the RUTF. With respect to vitamins and minerals, it is important to emphasise that children with acute malnutrition have high nutritional needs due to metabolic imbalances and the need to maintain rapid rates of growth during the recovery phase. In addition, high levels of certain minerals (magnesium, potassium and phosphorus), low levels of sodium and an adequate level of vitamin A and zinc are required for optimal recovery. In addition, essential fatty acids and highquality proteins enriched with micro-nutrients are also necessary to ensure that the high nutritional needs of recipients are met, allow the regeneration of tissue and permit the correction of micro-nutrient deficiencies which are common in these populations. Agree All added vitamins and minerals must be in accordance with the Advisory Lists of Nutrient Compounds for use in Foods for Special Dietary Uses Intended for Infants and Young Children (CXG ). Examples of vitamin and mineral forms for RUTF formulation can be found in the WHO Management of severe malnutrition: A manual for physicians and other senior health workers (1999). [The amount of vitamins and minerals added to achieve the target level must be adjusted based on the chemical form and scientific evidence showing adequate stability and bioavailability in the finished product.product without compromising the nutritional value] HKI supports that the 2007 Joint Statement (A Joint Statement by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children's Fund Community-based Management of Severe Acute Malnutrition) also be added as an example of vitamins and minerals for RUTF formulation. ICAAS suggests to add the following phrase to the sentence in brackets: interaction and impaired absorption with other nutrients and non-nutrients, so that the sentence currently in brackets is formulated as follows: [The amount of vitamins and minerals added to achieve the target level must be adjusted based on the chemical form, interaction and impaired absorption with other nutrients and non-nutrients and scientific evidence showing adequate stability and bioavailability in the finished product]. IBFAN The high phytoestrogen content of soybeans makes these unsuitable for the rehabilitation of children with SAM). Ecuador Argentina Brazil. We request clarification about the need of including the last sentence in square brackets since the CAC/GL sets criteria for the inclusion and deletion of nutrient compounds from the advisory lists which already consider stability and biologically availability (item 2.1). Colombia Ecuador India Jamaica HKI International Council on Amino Acid Science